Department of Neurosurgery, CHU de Nice
Nice, 06000, France
NCT Number: NCT00554528
The aim of the study is to evaluate the impact of the cervical disk surgery on the deterioration of the adjacent levels. The investigators compare the radiological deterioration of adjacent levels, at 3 years, in both situation of fusion and arthroplasty. 220 patients are enrolled and randomized to receive fusion or prosthesis. Radiological and clinical follow-up is organized for a period of 3 years.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 4
Nice, 06000, France
Anterior surgery of the cervical spine is one of the most practiced procedures in spine surgery. Its immediate accuracy and safety is proved since a long time in case of degenerative disk disease or disk herniation. But the segmental arthrodesis leads to an overload of the adjacent disk. A lot of studies have shown that the increasing mobility and pressure of the adjacent segments can be responsible of new degeneration and clinical symptoms. Recently, cervical disk prosthesis have been developed to maintain the mobility at the level of the surgery. This technique is supposed to decrease the risk of adjacent disk disease but, at this time, the analysis of the results is difficult, due to the lack of randomized studies with long term follow up.
The aim of our prospective randomized study is to evaluate the aftermath of the arthroplasty compared to the fusion on the adjacent disk degeneration.
The main objective is to show a radiological difference at 3 years in term of adjacent disk degeneration.
The secondary objectives are:
This is a controlled study with two group of equal size: one group is treated by discectomy and arthrodesis and the other by discectomy and prosthesis/ The criteria for the inclusion of the patients are: clinical radiculopathy and/or myelopathy due to a cervical disk disease (disk herniation or osteophytosis), lack of effect of the medical treatment, CT scan or MRI showing a compression of roots and/or spinal cord.
The main exclusion criteria are: plurisegmental disk disease, injuries happened during professional activities, previous cervical surgery.
During the study, we perform a clinical (standardized scales: Neck Disability Index, Short Form 36, and neurological exam) and a radiological (height of the adjacent disks, ostheophytis,…) follow-up.
The analysis of the current literature and statistical process leads to a total amount of 220 patients enrolled in the study. This is a multicentric study organized for a total duration of five years (two years for inclusions and three years of follow-up).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stage 1: partial discectomy
stage 2: location of the medial axis
stage 3: centering pin
stage 4: installation of the caspar spacer
stage 5: total discectomy
stage 6: parallel distraction
stage 7: depth measurement
stage 8: trial implant
stage 9: assembly
stage 10: implant insertion
stage 11: anchorage optimization
discectomy and arthrodesis
Time frame: 3 years after surgery
Time frame: during the 3 years of follow-up
Time frame: during the first month after surgery
Centre Hospitalier Universitaire de Nice
Other
Acronym: PROCERV
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